Reference Number: JO-2106-470505
GDP Quality Assurance Executive
Job Type: Permanent
Location: Central London / West End
Maintenance of the UK and Ireland Quality Management System (QMS):
- Ensuring that local quality release of batches of medicinal product for the UK & Ireland markets is performed in an accurate and timely manner and in compliance with regulatory requirements
- Ensure compliance with Global and Local Quality principles, standards, policies and SOPs
- Track operational Quality and Compliance
- Issuance of all documents used within the QMS, including maintenance and control of local SOPs, including alerting SOP owners of SOP review dates, tracking updates to the SOPs, performance of gap assessments between global and local procedures in a timely manner
- Author, review and approve SOPs as required
- In cooperation with other team members, prepare periodic Quality reports
- Review, process, track and close out Change Controls/Deviations/Risk Assessments, including liaising with relevant Heads of Department to perform root cause analysis, and to discuss and agree CAPAs
- Support and facilitate the roll-out of Global Electronic Document/Learning/Quality Management Systems as required by the business
- Ensure all personnel receive the necessary training via the e-learning systems and that training delivered follows Global standards:
- Ensure training matrix is in place for relevant staff with responsibilities defined within the QMS and documented appropriately
- Assist with the performance of Quality inductions for all new starters
- Assign relevant SOP training to all staff (including service providers) and ensure that training records are kept using the e-learning system
Education, Skill and Experience
- BSc in a scientific discipline.
- Experience working in a quality department or with managing quality related documentation (such as standard operating procedures) in another related function, such as Pharmacovigilance, Compliance or Finance
- Experience of writing and updating SOPs with clarity, accuracy, and rigor
- Knowledge of GDP requirements
- Experience of working within electronic quality and document management systems
- Experience of working with Enterprise resource planning (ERP) systems
- Excellent organizational, planning and time management skills.
- Computer literate, including Adobe Acrobat and Microsoft Word/Excel.
- Excellent attention to detail.
- Can effectively prioritise and manage multiple competing tasks and demands
- Appreciates and advocates the importance of being compliant and maintaining compliance records